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The Effectiveness and Safety of Body Posture to Improve Intracranial Pressure in Preventing Postoperative Recurrence for Chronic Subdural Hematoma (BP-CSDH) -A Multicenter randomized controlled clinical trial

The Effectiveness and Safety of Body Posture to Improve Intracranial Pressure in Preventing Postoperative Recurrence for Chronic Subdural Hematoma (BP-CSDH) -A Multicenter randomized controlled clinical trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500099281
Enrollment
Unknown
Registered
2025-03-20
Start date
2024-08-08
Completion date
Unknown
Last updated
2025-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Subdural Hematoma

Interventions

Control group:Conventional treatment
Intervention group:Positional therapy

Sponsors

Huashan Hospital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Chronic subdural hematoma confirmed by cranial imaging (CT or MR); hematoma thickness of not less than 1.0 cm; 2. Age>=60 years; 3. MGS-GCS score<=2; 4. Symptoms and/or neurological dysfunction caused by CSDH before surgery, such as headache, dizziness, nausea and vomiting, numbness or weakness of limbs, unsteady walking, unclear consciousness, unfavorable speech, slow response, etc.; 5. Patients undergoing borehole drainage; 6. Those who have obtained the patient's and their family's understanding of the purpose and needs of this study, consented to and signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Pregnant or lactating patients; 2. Patients with cerebral herniation, large-scale acute cerebral infarction, etc., who need emergency craniotomy or small bone window craniotomy to remove hematoma; 3. Patients with severe tumors, bleeding disorders or other known serious diseases (such as multiple organ failure, obvious cardiac insufficiency, severe lung inflammation) that affect the improvement of their condition or complete follow-up; 4. Combined with kyphotic deformity and other spinal deformities or suffering from mental illness, etc., unable to cooperate with long-term postural treatment; 5. Patients with intracranial tumors and intracranial aneurysms or vascular malformations; 6. CT of the head showed no obvious compression and displacement of brain tissue, no symptoms before surgery, and no obvious impact on one's normal life; Patients who do not consider surgical treatment necessary in the opinion of the neurosurgeon; 7. Patients with chronic subdural hematoma persisting for more than 1 year and significant organic solid hematoma; 8. Patients with chronic subdural hematoma caused by excessive drainage of ventriculoperitoneal shunt of hydrocephalus; 9. Patients with acute bleeding during drilling surgery, or even brain herniation requiring craniotomy; 10. Patients who have suffered cerebral contusion or tube insertion into the brain during drilling and drainage surgery; 11. Patients with venous thrombosis and pulmonary thrombosis of the lower limbs; 12. Patients who are expected to be unable to complete regular re-examination within 1 year due to various reasons; 13. Patients with an expected survival of less than 1 year; 14. Patients who are participating in other clinical trials; 15. Other conditions that are not suitable for enrollment (determined by 2 neurosurgeons); 16. Patients with reflux bile and esophageal diseases.

Design outcomes

Primary

MeasureTime frame
Recurrence rate of CSDH;

Secondary

MeasureTime frame
Change in modified Rankin Scale(mRS) compared to baseline;Change in EQ-5D-5L score compared to baseline;Differences between two group in comorbidities;Differences between two group in complications;Subdural hematoma recurrence rate without head injury;Comparison of CSDH recurrence rate of two group caused by whatever the reasons;Differences between two group in recurrence time;

Countries

China

Contacts

Public ContactXuehai Wu

Huashan Hospital Affiliated to Fudan University

wuxuehai2013@163.com+86 21 52887732

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026